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Stable Coronary Artery DiseaseP3NCT03782688

Precise Percutaneous Coronary Intervention Plan (P3) Study

An observational study of Stable Coronary Artery Disease, run by Onze Lieve Vrouw Hospital at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The PRECISE PERCUTANEOUS CORONARY INTERVENTION (PCI) PLAN STUDY is an investigator-initiated, international and multicenter study of patients with an indication for PCI aiming at assessing the agreement and accuracy of the HeartFlow Planner with invasive fractional flow reserve (FFR) as a reference. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stable Coronary Artery Disease
What is being tested?
FFRCT planner
How many people
127 participants
Where
1 siteBelgium
Study dates
1 Feb 2019to 18 Dec 2021
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Patients with Stable Coronary Artery Disease with Positive Fractional Flow Reserve and indication for percutaneous myocardial revascularization.

Who may be able to join

  • Coronary artery disease in a major epicardial vessel with an invasive fractional flow reserve (FFR) ≤0.80
  • An indication to Percutaneous coronary intervention

Who cannot join

  • Angiographic exclusion criteria
  • Severely calcified lesion/vessel
  • Bifurcation lesions.
  • Ostial lesions.
  • Left main disease.
  • Severe vessel tortuosity.
Show all 25Show fewer
  • Clinical exclusion criteria
  • Chronic obstructive pulmonary disease
  • Contraindication to adenosine
  • NYHA class III or IV, or last known left ventricular ejection fraction <30%
  • Uncontrolled or recurrent ventricular tachycardia
  • Atrial fibrillation, flutter or arrhythmia
  • History of recent stroke (≤90 days)
  • History of acute coronary syndrome (≤90 days)
  • Prior myocardial infarction
  • History of ischemic stroke (>90 days) with modified RANKIN score ≥ 2
  • History of any hemorrhagic stroke
  • Previous revascularization (PCI or Coronary artery bypass grafting)
  • Active liver disease or hepatic dysfunction, defined as AST or ALT > 3 times the ULN
  • Severe renal dysfunction, defined as an eGFR <30 mL/min/1.73 m2
  • Body mass index>35 kg/m2
  • Nitrate intolerance
  • Contra-indication to heart rate lowering drugs
  • Imaging-related
  • Insufficient coronary CT Angiography image quality.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • OLV-Aalst

    Aalst, Oost-Vlaanderen, 9300

Other trials in Belgium

About this study

Official title: Prospective Evaluation of a Virtual Non-invasive Percutaneous Intervention Planner in Patients With Coronary Artery Disease.

The PRECISE PERCUTANEOUS CORONARY INTERVENTION (PCI) PLAN STUDY is an investigator-initiated, international and multicenter study of patients with an indication for PCI aiming at assessing the agreement and accuracy of the HeartFlow Planner with invasive fractional flow reserve (FFR) as a reference.

Read the detailed description

Multicenter study, including 120 patients at 5 centers in Europe and Asia. After identifying the presence of significant coronary stenosis by means of coronary angiography and invasive fractional flow reserve (FFR≤0.80) the patients will undergo the following procedures: Invasive FFR with intravenous adenosine (i.e. pre- and post-PCI). Optical coherence tomography-guided PCI (i.e. pre- and post-procedural imaging). PCI with newer generation drug-eluting stent.

Being tested
FFRCT planner

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FFRCT plannerDiagnostic test

    Also called HeartFlow Planner

    Non-invasive post-PCI fractional flow reserve prediction

Study groups in NCT03782688
Study groupRoleWhat they receive
Single-arm cohortPatients with significant coronary stenosis by invasive fractional flow reserve (FFR≤0.80)
Receives: Diagnostic Test: FFRCT planner

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Agreement on post-PCI fractional flow reserve between virtual treatment based on FFRct planner and measured invasive post-PCI fractional flow reserve.

    The agreement will be assessed by Bland Altman method

    Measured: The primary endpoint will be assessed immediately after the procedure (PCI).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2018
  2. Study start1 Feb 2019
  3. Primary completion18 Dec 2020
  4. Study completion18 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
127 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03782688
Sponsor's protocol ID
CVBA-CRI_0001
Acronym
P3
Status last verified
Mar 2023
First submitted
12 Dec 2018
Last updated
23 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Undecided plan for data sharing

Publications

  • Seki R, Collison D, Ikeda K, Sonck J, Munhoz D, Bertolone DT, Ko B, Maeng M, Otake H, Koo BK, Storozhenko T, Bouisset F, Belmonte M, Leone A, Shumkova M, Ford TJ, Mahendiran T, Berry C, De Bruyne B, Oldroyd K, Sakai K, Mizukami T, Collet C. Validation of virtual fractional flow reserve pullback curves. Catheter Cardiovasc Interv. 2024 Nov;104(6):1178-1188. doi: 10.1002/ccd.31222. Epub 2024 Sep 29.

    PubMed 39342486

  • Yang S, Hwang D, Sakai K, Mizukami T, Leipsic J, Belmonte M, Sonck J, Norgaard BL, Otake H, Ko B, Maeng M, Moller Jensen J, Buytaert D, Munhoz D, Andreini D, Ohashi H, Shinke T, Taylor CA, Barbato E, De Bruyne B, Collet C, Koo BK. Predictors for Vulnerable Plaque in Functionally Significant Lesions. JACC Cardiovasc Imaging. 2025 Feb;18(2):195-206. doi: 10.1016/j.jcmg.2024.07.021. Epub 2024 Sep 11.

    PubMed 39269415

  • Candreva A, Gallo D, Munhoz D, Rizzini ML, Mizukami T, Seki R, Sakai K, Sonck J, Mazzi V, Ko B, Norgaard BL, Jensen JM, Maeng M, Otake H, Koo BK, Shinke T, Aben JP, Andreini D, Gallinoro E, Stahli BE, Templin C, Chiastra C, De Bruyne B, Morbiducci U, Collet C. Influence of intracoronary hemodynamic forces on atherosclerotic plaque phenotypes. Int J Cardiol. 2024 Mar 15;399:131668. doi: 10.1016/j.ijcard.2023.131668. Epub 2023 Dec 22.

    PubMed 38141723

  • Sakai K, Mizukami T, Leipsic J, Belmonte M, Sonck J, Norgaard BL, Otake H, Ko B, Koo BK, Maeng M, Jensen JM, Buytaert D, Munhoz D, Andreini D, Ohashi H, Shinke T, Taylor CA, Barbato E, Johnson NP, De Bruyne B, Collet C. Coronary Atherosclerosis Phenotypes in Focal and Diffuse Disease. JACC Cardiovasc Imaging. 2023 Nov;16(11):1452-1464. doi: 10.1016/j.jcmg.2023.05.018. Epub 2023 Jul 19.

    PubMed 37480908

  • Mizukami T, Sonck J, Sakai K, Ko B, Maeng M, Otake H, Koo BK, Nagumo S, Norgaard BL, Leipsic J, Shinke T, Munhoz D, Mileva N, Belmonte M, Ohashi H, Barbato E, Johnson NP, De Bruyne B, Collet C. Procedural Outcomes After Percutaneous Coronary Interventions in Focal and Diffuse Coronary Artery Disease. J Am Heart Assoc. 2022 Dec 6;11(23):e026960. doi: 10.1161/JAHA.122.026960. Epub 2022 Nov 29.

    PubMed 36444858

  • Sonck J, Nagumo S, Norgaard BL, Otake H, Ko B, Zhang J, Mizukami T, Maeng M, Andreini D, Takahashi Y, Jensen JM, Ihdayhid A, Heggermont W, Barbato E, Mileva N, Munhoz D, Bartunek J, Updegrove A, Collinsworth A, Penicka M, Van Hoe L, Leipsic J, Koo BK, De Bruyne B, Collet C. Clinical Validation of a Virtual Planner for Coronary Interventions Based on Coronary CT Angiography. JACC Cardiovasc Imaging. 2022 Jul;15(7):1242-1255. doi: 10.1016/j.jcmg.2022.02.003. Epub 2022 Apr 13.

    PubMed 35798401

Questions about this trial

What is this clinical trial studying?

An observational study of Stable Coronary Artery Disease, run by Onze Lieve Vrouw Hospital at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Agreement on post-PCI fractional flow reserve between virtual treatment based on FFRct planner and measured invasive post-PCI fractional flow reserve. (time frame: The primary endpoint will be assessed immediately after the procedure (PCI).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03782688, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.

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